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Drugs@FDA: FDA-Approved Drugs

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Abbreviated New Drug Application (ANDA): 219161
Company: NOVITIUM PHARMA

Products on ANDA 219161

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	TE Code	RLD	RS
OMEPRAZOLE AND SODIUM BICARBONATE	OMEPRAZOLE; SODIUM BICARBONATE	20MG/PACKET;1.68GM/PACKET	FOR SUSPENSION;ORAL	Prescription	AB	No	No
OMEPRAZOLE AND SODIUM BICARBONATE	OMEPRAZOLE; SODIUM BICARBONATE	40MG/PACKET;1.68GM/PACKET	FOR SUSPENSION;ORAL	Prescription	AB	No	No

Approval Date(s) and History, Letters, Labels, Reviews for ANDA 219161

Original Approvals or Tentative Approvals

Action Date	Submission	Action Type	Submission Classification	Review Priority; Orphan Status	Letters, Reviews, Labels, Patient Package Insert	Notes	Url
12/10/2025	ORIG-1	Approval		STANDARD		Label is not available on this site.

Therapeutic Equivalents for ANDA 219161

OMEPRAZOLE AND SODIUM BICARBONATE

FOR SUSPENSION;ORAL; 20MG/PACKET;1.68GM/PACKET
TE Code = AB

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	RLD	TE Code	Application No.	Company
OMEPRAZOLE AND SODIUM BICARBONATE	OMEPRAZOLE; SODIUM BICARBONATE	20MG/PACKET;1.68GM/PACKET	FOR SUSPENSION;ORAL	Prescription	No	AB	205545	AJANTA PHARMA LTD
OMEPRAZOLE AND SODIUM BICARBONATE	OMEPRAZOLE; SODIUM BICARBONATE	20MG/PACKET;1.68GM/PACKET	FOR SUSPENSION;ORAL	Prescription	No	AB	219161	NOVITIUM PHARMA
OMEPRAZOLE AND SODIUM BICARBONATE	OMEPRAZOLE; SODIUM BICARBONATE	20MG/PACKET;1.68GM/PACKET	FOR SUSPENSION;ORAL	Prescription	No	AB	079182	STRIDES PHARMA INTL

FOR SUSPENSION;ORAL; 40MG/PACKET;1.68GM/PACKET
TE Code = AB

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	RLD	TE Code	Application No.	Company
OMEPRAZOLE AND SODIUM BICARBONATE	OMEPRAZOLE; SODIUM BICARBONATE	40MG/PACKET;1.68GM/PACKET	FOR SUSPENSION;ORAL	Prescription	No	AB	205545	AJANTA PHARMA LTD
OMEPRAZOLE AND SODIUM BICARBONATE	OMEPRAZOLE; SODIUM BICARBONATE	40MG/PACKET;1.68GM/PACKET	FOR SUSPENSION;ORAL	Prescription	No	AB	219161	NOVITIUM PHARMA
OMEPRAZOLE AND SODIUM BICARBONATE	OMEPRAZOLE; SODIUM BICARBONATE	40MG/PACKET;1.68GM/PACKET	FOR SUSPENSION;ORAL	Prescription	No	AB	079182	STRIDES PHARMA INTL

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